# Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway

> **NCT05194124** · PHASE3 · COMPLETED · sponsor: **Rhythm Pharmaceuticals, Inc.** · enrollment: 19 (actual)

## Conditions studied

- Bardet-Biedl Syndrome
- POMC Deficiency

## Interventions

- **DRUG:** Setmelanotide 2 mg
- **DRUG:** Setmelanotide 2.5 mg
- **DRUG:** Setmelanotide 3 mg
- **DRUG:** Setmelanotide 20 mg
- **DRUG:** Setmelanotide 25 mg
- **DRUG:** Setmelanotide 30 mg

## Key facts

- **NCT ID:** NCT05194124
- **Lead sponsor:** Rhythm Pharmaceuticals, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-12-21
- **Primary completion:** 2023-10-19
- **Final completion:** 2023-10-19
- **Target enrollment:** 19 (ACTUAL)
- **Last updated:** 2024-11-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05194124

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05194124, "Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway". Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/clinical/NCT05194124. Licensed CC0.

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